LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08
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OptoMonitor 3 Handle Unit (OpM3-HU)
The OptoMonitor 3 Handle Unit provides the link between the OptoWire pressure guidewire and the
Optical Unit. The Handle Unit also has an LED on its front face that alerts the user in various ways (see
section 3.6.2).
The Handle Unit has a square green port on its front face which is meant for OptoWire connection, as
well as a smaller slot connection for the gauge factor connector (where applicable).
NOTE
: The Handle Unit must be placed outside the sterile field.
Accessories
OptoWire Pressure Guidewire (not supplied)
The OpSens OptoWire Pressure Guidewire provides the distal pressure required to calculate both the
dPR and FFR. This accessory is a single use.
Please contact your representative for OptoWire purchase.
Please refer to OptoWire IFU for the following:
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Disposal of unit after use
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As applicable, the appropriate process for cleaning and packaging
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Sterilization method
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Necessary instructions in the event of damage to sterile packaging
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Precautions to be taken in the event of changes to the performance of the OW as a result of
ageing and environmental conditions.
Aortic transducer (supplied by others)
The Optical Unit uses the signals from OptoWire and an Aortic Pressure input to calculate both the dPR
and FFR.
The aortic pressure reading can be obtained either from a Cathlab Hemodynamic System, via AUX input,
or an aortic transducer, via Aortic Transducer Input. If using a direct connection to the Aortic
Transducer, the transducer shall meet the following requirements:
ANSI/AAMI BP22 compliant transducer with the following specifications:
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Sensitivity : 5uV/V/mmHg
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Excitation voltage : 4 to 8 Vrms